A Multi-component, Person-centered, and Yoga-based Coaching Program for Lupus Chronic Pain

Study Purpose

This research will assess the feasibility of a tailored yoga coaching program for reducing pain-related symptoms among people with systemic lupus erythematosus.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions. 2. Diagnosed with systemic lupus erythematosus (SLE). In this study, SLE is classified as meeting the 2019 European League Against Rheumatism/American College of Radiology (ACR) criteria for SLE. 3. Stable doses of lupus-related medications, including prednisone, for 3 months prior to study entry. 4. Reports pain lasting ≥ 3 months and has a sum of ≥8 on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Pain Interference items (assessed at screening). 5. Willingness to attend all study visits, including attending recorded virtual coaching sessions for the duration of study. 6. Willingness to engage in yoga practices outlined in the MiPAL program. 7. Access to necessary resources for participating in a remote intervention, including a smartphone, computer, or tablet with internet.

Exclusion Criteria:

1. Taking >10 mg of prednisone (or equivalent steroid dose) per day. 2. Unable to attend study visits. 3. Pregnancy. 4. Concurrent participation in other behavioral, psychotherapeutic, or pharmacological trials. 5. Any impairment, activity, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol. For example, any condition that impairs the ability to give consent or participate fully in the study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07196072
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Michigan
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rachel Bergmans, MPH, PhDDominique Kinnett-Hopkins, PhD
Principal Investigator Affiliation	University of MichiganUniversity of Michigan
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	SLE (Systemic Lupus), Chronic Pain

Arms & Interventions

Arms

Experimental: MiPAL participant

All study participants who meet eligibility criteria.

Interventions

Behavioral: - MiPAL

MiPAL participants meet with a coach to co-develop a self-directed yoga practice based on individual preferences and limitations.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Michigan, Ann Arbor 4984247, Michigan 5001836

Status

Recruiting

Address

University of Michigan

Ann Arbor 4984247, Michigan 5001836, 48109

Site Contact

Vivian Kurtz, MPH

[email protected]

734-998-7156

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